NCT02620878

Artificial Pancreas in Pediatric Patients (PEDarPAN)

Use of Artificial Pancreas in Pediatric Patients. Feasibility , Safety and Efficacy Study of an Automatic Control of Blood Glucose 24/24 at a Diabetes Camp

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: University of Padova · Academic / Other
• Sex: All
• Age: 6 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine safety, feasibility and efficacy (with respect to sensor- augmented pump therapy) of an Artificial Pancreas (AP) prototype in day and night closed-loop control in children and adolescents with type 1 diabetes.

Detailed description

The AP prototype is based on a Modular Model Predictive Control algorithm (MMPC) implemented on the Diabetes Assistant (DiAs) wearable platform. The study will be divided in two parts: the first part will serve as a 3 days pilot study and will be conducted in a hotel/residence near the hospital. The investigators will recruit 6/8 children (5-12 years) and/or 6/8 adolescents (12-18 years), with type 1 diabetes who have experience with insulin pump. DiAs will be used 72 continuous hours of day and night. If part 1 will be successfully, after about 2-3 months, the study will move to the second part (the main part), that will consist in cross-over randomized study that will be conducted in a camp setting. The participants will be randomly assigned to the treatment arm (Artificial Pancreas) or to the control arm (sensor-augmented insulin pump). Then the same patient will be assigned to the other arm. Each treatment will be applied 3 consecutive days. During the first period (days 1-3) patients will do the same activites and will have the same diet as in the second period (day s 5-7). The investigators will recruit 30/40 children (5-12 years) and/or 30/40 adolescents (12-18 years), affected by type 1 diabetes who have experience with insulin pump therapy. The study has the permission of the Ethics Committee reference and the permission for "clinical investigation with devices not CE marked" by the Health Ministry.

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
DEVICE	artificial pancreas	Patients will be randomly assigned to receive either 3 days of automated closed-loop insulin delivery (intervention) followed by 3 days of sensor -augmented pump therapy (control), or the inverted sequence.
OTHER	sensor augmented pump	During this control period (comparator arm) the patients will use sensor augmented pump. This period will be compared to the same period of artificial pancreas

Timeline

• Start date: 2015-07-01
• Primary completion: 2015-09-01
• Completion: 2015-09-01
• First posted: 2015-12-03
• Last updated: 2019-07-12
• Results posted: 2019-07-12

Locations

1 site across 1 country: Italy